Uronephrological Complications Risk Factors in Spinal Dysraphism

Spinal Dysraphism Clinical Trial

— RUD  

Official title:

Individualisation of Uronephrological Complications Risk Factors in Spinal Dysraphism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05718440
• Other study ID #: APHP221008
• Status: Recruiting
• Start date: November 6, 2023
• Est. completion date: November 2028

Study information

• Verified date: April 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Maelys Teng, MD, MSc
• Phone: 0156017954
• Email: maelys.teng[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Spinal dysraphism consist of congenital malformations resulting of abnormalities in the formation of neural tube and/or surrounding structures during embryogenesis. The aim of this study is to assess if there are specific clinical and paraclinical patterns of pelvic (urinary, bowel, sexual) disorders depending on the dysraphism's type and level of injury.

This description will help to determine a prognosis on symptoms and the risk of complication depending on the dysraphism's type and level of injury. It will provide targeted evaluation and cares: identifying patients who will be at risk of complications and needing acute monitoring or preventing cares on the symptoms' onset.

Pelvic disorders have an important impact on morbi-mortality (urinary dysfunction is the first cause of mortality in adults by renal failure or infection) and also on patients' quality of life.

Description:

Spinal dysraphism consist of congenital malformations resulting of abnormalities in the formation of neural tube and/or surrounding structures during embryogenesis. The aim of this study is to assess if there are specific clinical and paraclinical patterns of pelvic (urinary, bowel, sexual) disorders depending on the dysraphism's type and level of injury.

This description will help to determine a prognosis on symptoms and the risk of complication depending on the dysraphism's type and level of injury. It will provide targeted evaluation and cares: identifying patients who will be at risk of complications and needing acute monitoring or preventing cares on the symptoms' onset.

Pelvic disorders have an important impact on morbi-mortality (urinary dysfunction is the first cause of mortality in adults by renal failure or infection) and also on patients' quality of life.

This is an observational descriptive study with prospective inclusions of patients over 18 years old with spinal dysraphism, evaluated for urinary, anorectal, sexual dysfunctions in a one-day hospitalization.

Inclusions will be recorded during this one-day hospitalization. On this day, patients will have a medical consultation and data concerning medical history, treatments, pelvic disorders' characteristics and physical examination will be recorded. They will answer questionnaires on pelvic dysfunctions, quality of life, anxiety and depression, cognitive disorders and self-catheterizations' adherence or difficulties. They will also undergo urodynamics. In case of peripheral neurological pattern, a perineal electrophysiology will be done with recording of bulbocavernosus reflex latency and somatosensory evoked potentials.

Outpatient examinations (urinary ultrasound, urethrocystography, anorectal manometry, defecography blood test with serum creatinine, glycemia, TSH, lipids) will be collected at the next consultation.

Patients' participation will last 12 months maximum (time period between the one-day hospitalization (inclusion) and the follow up consultation where the outpatients' examinations results will be recorded).

A better understanding of pelvic dysfunctions, according to neurological systematization and type of spinal dysraphism, will help to focus the evaluation and therapeutic managements on patients with spinal dysraphism at risk of uronephrological complications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2028
• Est. primary completion date: November 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• men and women over 18 years old with spinal dysraphism,

• urinary and/or bowel and/or sexual dysfunction,

• evaluated in a one day consultation in a neuro-urology department.

• Informed consent is required from the patient or his tutor/curator if he is under legal protection

Exclusion Criteria:

• language barrier with non-understanding of French language,

• other neurologic pathologies except syringomyelia, Chiari malformation or hydrocephalus who are often associated to spinal dysraphism.

Related Conditions & MeSH terms

• Neural Tube Defects
• Spinal Dysraphism

Intervention

Other:
• Individualisation of uronephrological complications risk factors
description of pelvic disorders in terms of clinical presentation, electrophysiology/urodynamics/anorectal manometry patterns, urethrocystography/urinary ultrasound/defecography results and urinary complications (infections, vesicoureteral reflux), depending on the dysraphim's type and level of injury and to correlate these parameters to the uronephrological risk factors and complications recorded.

Locations

Country	Name	City	State
France	Tenon hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sexual dysfunctions in term of spinal dysraphisms	Sexual dysfonctions according the scale Men Health Sexual Questionnaire (MHSQ) score between 5 to 125 (no problem)	1 day
Primary	patient quality of life	questionnaire "Qualiveen" (quality of life linked to health) to be completed by patient (score between 0 (no problem) to 4)	1 day
Primary	Urinary disorders	Urinary Symptom Profile (USP) questionnaire (score between 0 (no problem) to 39)	1 day
Primary	cognitive disorders	Montreal Cognitive Assessment (MOCA) scale (score between 0 to 30, normal between >=26)	1 day
Primary	pelvic disorders description thanks to exams	urinary echography, anorectal manometry and defecography will be performed in order to described pelvic disorders n.	1 day
Secondary	urinary complications	number of infections, vesicoureteral reflux	1 day